Flucostat caps. 150mg No. 1

Release form, composition and packaging

Opaque capsules, white, No. 0

the contents of the capsules are white or almost white powder.

1 caps.

fluconazole 150 mg

colloidal silicon dioxide (aerosil), corn starch, magnesium stearate, sodium lauryl sulfate, lactose.

The composition of the capsule shell: gelatin, methyl parahydroxybenzoate, propyl parahydroxybenzoate, titanium dioxide (E171), acetic acid.

7 pcs.

- contour cell packaging (500) - cardboard boxes.

1 PC.

- contour cell packaging (1) - cardboard packs.

2 pcs.

- contour cell packaging (1) - cardboard packs.

1 PC.

- contoured cell packaging (500) - cardboard boxes.

2 pcs.

- contour cell packaging (500) - cardboard boxes.

pharmachologic effect

Antifungal drug.

Fluconazole, a representative of the class of triazole antifungal agents, is a potent selective inhibitor of sterol synthesis in the fungal cell.

Active against pathogens of opportunistic mycoses, incl.

caused by Candida spp., Cryptococcus neoformans, Microsporum spp., Trichophyton spp.

The activity of fluconazole has also been shown in models of endemic mycoses, including infections caused by Blastomyces dermatitidis, Coccidioides immitis and Histoplasma capsulatum.

Pharmacokinetics

Suction

After oral administration, fluconazole is well absorbed.

Bioavailability is 90%.

Cmax of fluconazole in blood plasma after taking on an empty stomach at a dose of 150 mg is 90% of its content in plasma when administered intravenously at a dose of 2.5-3.5 mg / l.

Tmax is achieved within 0.5-1.5 hours after administration.

Concomitant food intake does not affect oral absorption.

Plasma concentration is directly proportional to the dose taken.

Distribution

90% Css is achieved by 4-5 days of drug treatment (when taken 1 time / day).

The introduction of a loading dose (on the 1st day), 2 times the average daily dose, makes it possible to reach 90% Css level by the 2nd day.

The apparent Vd approaches the total body water content.

Protein binding - 11-12%.

Fluconazole penetrates well into all body fluids.

Concentrations of fluconazole in saliva and sputum are similar to those in plasma.

In patients with fungal meningitis, the concentration of fluconazole in the cerebrospinal fluid is about 80% of its plasma levels.

In the stratum corneum, epidermis, dermis and sweat fluid, high concentrations are reached, which exceed serum concentrations.

Withdrawal

T1 / 2 is about 30 hours.

Fluconazole is excreted mainly by the kidneys

approximately 80% of the administered dose is found unchanged in the urine.

Fluconazole clearance is proportional to CC.

Fluconazole metabolites were not detected in the blood.

Indications for use

- cryptococcosis, including cryptococcal meningitis and other localizations of this infection (including lungs, skin), both in patients with a normal immune response and in patients with various forms of immunosuppression (including AIDS patients, during transplantation organs)

the drug can be used to prevent cryptococcal infection in AIDS patients

- generalized candidiasis, including candidemia, disseminated candidiasis and other forms of invasive candidiasis infection (including infections of the peritoneum, endocardium, eyes, respiratory and urinary tract).

Treatment can be carried out in patients with malignant neoplasms, patients in intensive care units, patients receiving cytotoxic or immunosuppressive drugs, as well as in the presence of other factors predisposing to the development of candidiasis

- candidiasis of the mucous membranes, incl.

oral cavity and pharynx (including atrophic candidiasis of the oral cavity associated with wearing dentures), esophagus, non-invasive bronchopulmonary infections, candiduria

prevention of recurrence of oropharyngeal candidiasis in AIDS patients

- genital candidiasis: treatment of vaginal candidiasis (acute and chronic recurrent), prophylactic use in order to reduce the frequency of relapses of vaginal candidiasis (3 and b

Name ENG

FLUCOSTAT

Clinical and pharmacological group

Antifungal drug

ATX code

Fluconazole

Dosage

150mg

Structure

1 capsule contains: active substance: fluconazole 150 mg

excipients: lactose, corn starch, silicon dioxide, magnesium stearate, sodium sulfate.

Indications

cryptococcosis, including cryptococcal meningitis and other localizations of this infection (including lungs, skin), both in patients with a normal immune response and in patients with various forms of immunosuppression (including AIDS patients, organ transplantation )

the drug can be used to prevent cryptococcal infection in AIDS patients

generalized candidiasis, including candidemia, disseminated candidiasis, and other forms of invasive candidiasis (including infections of the peritoneum, endocardium, eyes, respiratory and urinary tract).

Treatment can be carried out in patients with malignant neoplasms, patients in intensive care units, patients receiving cytotoxic or immunosuppressive drugs, as well as in the presence of other factors predisposing to the development of candidiasis

candidiasis of the mucous membranes, incl.

oral cavity and pharynx (including atrophic candidiasis of the oral cavity associated with wearing dentures), esophagus, non-invasive bronchopulmonary infections, candiduria

prevention of recurrence of oropharyngeal candidiasis in AIDS patients

genital candidiasis: treatment of vaginal candidiasis (acute and chronic recurrent), prophylactic use in order to reduce the frequency of relapses of vaginal candidiasis (3 or more episodes per year)

candidal balanitis

prevention of fungal infections in patients with malignant neoplasms who are predisposed to such infections as a result of cytotoxic chemotherapy or radiation therapy

mycoses of the skin, including mycoses of the feet, body, groin, pityriasis versicolor, onychomycosis and candidiasis of the skin

deep endemic mycoses, including coccidioidomycosis, paracoccidioidomycosis, sporotrichosis and histoplasmosis in patients with normal immunity.

Contraindications

concomitant use of drugs that prolong the QT interval (including terfenadine or astemizole)

children under 3 years old

hypersensitivity to the drug or azole compounds similar in structure.

The drug should be used with caution in hepatic and / or renal failure, while taking potentially dangerous hepatotoxic drugs, with alcoholism, in the case of proarrhythmogenic conditions in patients with multiple risk factors (organic heart disease, electrolyte imbalance, concomitant use of drugs that cause arrhythmias).

Storage conditions and periods

At a temperature not higher than 25 degrees.

Expiration date: 3 years

INN / Active ingredient

fluconazole

Specifications

Category

Thrush

Scope of the drug

Gynecology

Release form

Capsules

Manufacturer country

Russia

Package quantity, pcs

one

Way of introduction

Through the mouth

Vacation conditions

Without recipe

Brand name

OTCPharm

The amount of the dosage form in the primary package

1 PC.

Primary packaging type

Blister

Type of consumer packaging

Pack of cardboard

Pharmaco-therapeutic group

Antifungal agent

Anatomical and therapeutic characteristics

J02AC01 Fluconazole

Dosage form

Capsules

Expiration date in days

1095

Dosage (volume) of the substance in the preparation

150 mg

Package weight, g

twenty

Mode of application

:

Inside. < br> For cryptococcal infections, candidemia, disseminated candidiasis and other invasive candidiasis infections: on the 1st day - 400 mg, then - 200-400 mg 1 time per day. < br> For the prevention of recurrence of cryptococcal meningitis in AIDS patients after a full course of primary treatment: 200 mg / day for a long period. < br> For atrophic oral candidiasis associated with wearing dentures: 50 mg once a day for 10-14 days. < br> For other candidal infections of the mucous membranes membranes: 50-100 mg / day for 14-30 days. < br> For the prevention of recurrence of oropharyngeal candidiasis in AIDS patients after the completion of the full course of primary treatment: 150 mg 1 time per week. < br> For vaginal candidiasis and balanitis: single dose 150 mg. For the prevention of relapses - 150 mg once a month,within 4-12 months. < br> For the prevention of candidiasis in cancer patients during cytostatic chemotherapy or radiation therapy: 50-400 mg 1 time per day. If there is a high risk of developing a generalized infection: 400 mg once a day a few days before the expected appearance of neutropenia after an increase in the number of neutrophils more than 1000 / mm3, treatment is continued for another 7 days. < br> With mycoses of the skin (feet, groin, etc.), including candidiasis infections: 150 mg once a week or 50 mg once per day. Duration of therapy - 2-4 weeks, with mycoses of the feet - up to 6 weeks. < br> With pityriasis versicolor: 50 mg once a day for 2-4 weeks. < br> With onychomycosis: 150 mg once a week until growing uninfected nail (3–6 and 6–12 months for nails of fingers and toes, respectively). < br> With deep endemic mycoses:200-400 mg / day for 11-24 months (coccidioidomycosis), 2-17 months (paracoccidioidomycosis), 1-16 months (sporotrichosis), 3-17 months (histoplasmosis). < br> Children with mucous membrane candidiasis at 1 day - 6 mg / kg / day, then - 3 mg / kg / day, with systemic candidiasis or cryptococcosis - 6-12 mg / kg, depending on the severity of the disease. For prophylaxis against the background of reduced immunity (depending on the severity of neutropenia) - 3-12 mg / kg / day.

Information on technical characteristics, delivery set, country of manufacture